GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a
FDA device recall Z-1092-2009 · posted 2009-03-12 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
- Action taken
- On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 4
- Distribution
- Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
- Date initiated
- 2008-03-06
- Date posted
- 2009-03-12
- Date terminated
- 2014-09-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |